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אישור FDA בדרך עד לרבעון הראשון של 2025, הצוות המסחרי בארה"ב נבנה בהתקדמות
החברה ממומנת במלואה במזומנים עד אמצע 2026
מונט-סנט-גיברט, בלגיה, 6 בנובמבר 2024, (GLOBE NEWSWIRE) :
Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024.
דגשים פיננסיים ותפעוליים אחרונים
*הציגה תוצאות משכנעות של נתוני DREAM באגודה הבינלאומית לשינה כירורגית בספטמבר.
*גייסה 24.6 מיליון אירו באמצעות תוכנית ATM מקרן ייעודית אחת לשירותי בריאות בארה"ב, מצטברת מצטרפת המאפשרת התאמות בשלבים לקראת המעבר למסחור בארה"ב והארכת יתרת המזומנים עד אמצע 2026.
*חיזוק הארגון בארה"ב עם העסקתו של ג'ון לנדרי כמנהל כספים והצטרפותם של מספר מנהלים מסחריים מובילים בארה"ב.
*דיווחה על מכירות של 1.3 מיליון אירו ברבעון השלישי, המייצגים צמיחה של 30% לעומת הרבעון השלישי של 2023.
*יתרת מזומנים כוללת של 71.0 מיליון אירו בסוף הרבעון, 95.6 מיליון אירו פרופורמה כולל 24.6 מיליון אירו שגויסו.
REGULATED INFORMATION
Nyxoah Reports Third Quarter Financial and Operating Results
FDA approval on track for first quarter 2025, U.S. commercial team build out in progresss
Company fully funded with cash until mid 2026
Mont-Saint-Guibert, Belgium – November 6, 2024, (GLOBE NEWSWIRE)–
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024.
Recent Financial and Operating Highlights
- Presented compelling DREAM data results at International Surgical Sleep Society in September.
- Raised €24.6 million through an ATM program from a single U.S. healthcare-dedicated fund providing incremental flexibility as we shift into U.S. commercialization and extending cash runway until mid 2026.
- Strengthened U.S. organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
- Reported third quarter sales of €1.3 million, representing 30% growth versus third quarter 2023.
- Total cash position of €71.0 million at the end of the quarter, €95.6 million proforma including the €24.6 million raised.
“Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval.”
Third Quarter 2024 Results
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
| For the three months ended September 30, | For the nine months ended September 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Revenue | 1,266 | 976 | 3,258 | 2,524 | ||||
| Cost of goods sold | (482) | (336) | (1,217) | (930) | ||||
| Gross profit | € 784 | € 640 | € 2,041 | € 1,594 | ||||
| Research and Development Expense | (7,902) | (6,568) | (22,573) | (19,330) | ||||
| Selling, General and Administrative Expense | (8,042) | (5 058) | (20,396) | (16,794) | ||||
| Other income/(expense) | 180 | − | 430 | 265 | ||||
| Operating loss for the period | €(14,980) | €(10,986) | €(40,498) | €(34,265) | ||||
| Financial income | 1,138 | 2,178 | 4,615 | 3,592 | ||||
| Financial expense | (3,043) | (1,033) | (5,480) | (2,765) | ||||
| Loss for the period before taxes | €(16,885) | €(9,841) | €(41,363) | €(33,438) | ||||
| Income taxes | (173) | 2,229 | (724) | 1,119 | ||||
| Loss for the period | €(17,058) | €(7,612) | €(42,087) | €(32,319) | ||||
| Loss attributable to equity holders | €(17,058) | €(7,612) | €(42,087) | €(32,319) | ||||
| Other comprehensive income/(loss) | ||||||||
| Items that may not be subsequently reclassified to profit or loss (net of tax) | ||||||||
| Currency translation differences | (209) | (10) | (221) | (88) | ||||
| Total comprehensive loss for the year, net of tax | €(17,267) | € (7,622) | €(42,308) | €(32,407) | ||||
| Loss attributable to equity holders | €(17,267) | € (7,622) | €(42,308) | (32,407) | ||||
| Basic loss per share (in EUR) | €(0.496) | €(0.266) | €(1.346) | €(1.166) | ||||
| Diluted loss per share (in EUR) | €(0.496) | €(0.266) | €(1.346) | €(1.166) | ||||
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
| As at | |||||
| September 30, 2024 |
December 31, 2023 | ||||
| ASSETS | |||||
| Non-current assets | |||||
| Property, plant and equipment | 4,461 | 4,188 | |||
| Intangible assets | 49,558 | 46,608 | |||
| Right of use assets | 3,635 | 3,788 | |||
| Deferred tax asset | 53 | 56 | |||
| Other long-term receivables | 1,475 | 1,166 | |||
| € 59,182 | € 55,806 | ||||
| Current assets | |||||
| Inventory | 5,272 | 3,315 | |||
| Trade receivables | 2,504 | 2,758 | |||
| Other receivables | 2,992 | 3,212 | |||
| Other current assets | 1,837 | 1,318 | |||
| Financial assets | 42,299 | 36,138 | |||
| Cash and cash equivalents | 28,678 | 21,610 | |||
| € 83,582 | € 68,351 | ||||
| Total assets | € 142,764 | € 124,157 | |||
| EQUITY AND LIABILITIES | |||||
| Capital and reserves | |||||
| Capital | 5,908 | 4,926 | |||
| Share premium | 290,906 | 246,127 | |||
| Share based payment reserve | 8,943 | 7,661 | |||
| Other comprehensive income | (84) | 137 | |||
| Retained loss | (200,966) | (160,829) | |||
| Total equity attributable to shareholders | 104,707 | € 98,022 | |||
| LIABILITIES | |||||
| Non-current liabilities | |||||
| Financial debt | 19,143 | 8,373 | |||
| Lease liability | 2,636 | 3,116 | |||
| Pension liability | 47 | 9 | |||
| Provisions | 398 | 185 | |||
| Deferred tax liability | 12 | 9 | |||
| €22,236 | € 11,692 | ||||
| Current liabilities | |||||
| Financial debt | 399 | 364 | |||
| Lease liability | 1,151 | 851 | |||
| Trade payables | 7,109 | 8,108 | |||
| Current tax liability | 2,495 | 1,988 | |||
| Other payables | 4,667 | 3,132 | |||
| € 15,821 | € 14,443 | ||||
| Total liabilities | € 38,057 | € 26,135 | |||
| Total equity and liabilities | € 142,764 | € 124,157 | |||
Revenue
Revenue was €1.3 million for the third quarter ending September 30, 2024, compared to €1.0 million for the third quarter ending September 30, 2023.
Cost of Goods Sold
Cost of goods sold was €482,000 for the three months ending September 30, 2024, representing a gross profit of €0.8 million, or gross margin of 62.0%. This compares to total cost of goods sold of €336,000 in the third quarter of 2023, for a gross profit of €0.6 million, or gross margin of 66.0%.
Research and Development
For the third quarter ending September 30, 2024, research and development expenses were €7.9 million, versus €6.6 million for the third quarter ending September 30, 2023.
Operating Loss
Total operating loss for the third quarter ending September 30, 2024, was €15.0 million versus €11.0 million in the third quarter ending September 30, 2023. This increase was primarily driven by expanded commercial activities, higher R&D investments, and ongoing clinical activities.
Cash Position
As of September 30, 2024, cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €5.6 million per month during the third quarter 2024.
Third Quarter 2024
Nyxoah’s financial report for the third quarter 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Wednesday, November 6, 2024, beginning at 10:30pm CET / 4:30pm ET.
A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q3 2024 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: Nyxoah’s Q3 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.
The archived webcast will be available for replay shortly after the close of the call.
About Nyxoah
Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.
